Nov 12, 2001
Results of Guidant's Next Generation Intravascular Radiotherapy System Clinical Trial Revealed

GALILEO INHIBIT Trial Presented Today at American Heart Association Meeting

Indianapolis, Ind. and Anaheim, Calif. - The results of Guidant Corporation's (NYSE and PCX: GDT) GALILEO INHIBIT trial were revealed today at the American Heart Association (AHA) meeting in Anaheim, California. The latest investigational GALILEO(tm) Intravascular Radiotherapy System seeking U.S. Food and Drug Administration (FDA) approval is designed to make it easier for physicians to treat longer coronary lesions (blockages) by incorporating an automatic stepping function. In-stent restenosis - the recurrence of a blockage in a coronary artery that had been previously propped open with a coronary stent - affects as many as 20 percent of patients treated with coronary stents each year.

"Guidant is pleased with the results of the GALILEO INHIBIT trial. These results build on the momentum of our recent approval in the U.S. of Guidant's GALILEO system and is evidence of our commitment to continually advance our technologies to address significant clinical challenges," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant Corporation. "The development of intravascular radiotherapy, along with current and future technologies such as drug-coated stents, demonstrates Guidant's commitment to provide physicians a comprehensive line of products to treat coronary artery disease."

Earlier this month, Guidant received FDA approval of its GALILEO(tm) Intravascular Radiotherapy System for use in treating in-stent restenosis. Guidant is pursuing an aggressive installation program to meet the needs of its customers, who are very excited to adopt this technology.

The new GALILEO Intravascular Radiotherapy System seeking FDA approval features automated stepping, which is intended to provide physicians an easier method to treat longer lesions. The system is designed to deliver radiation therapy starting at the far end of the blockage and automatically stepping the radiation treatment through a catheter to treat the programmed length of the artery needing therapy. This new system received CE Mark approval in July and is currently available in Europe.

Clinical research was presented today by Ron Waksman, M.D., at the 74th Scientific Sessions of the American Heart Association. Dr. Waksman was the primary investigator of the trial and is the associate director, Division of Cardiology, Washington Hospital Center, and the director of experimental angioplasty and vascular brachytherapy for the Cardiovascular Research Institute at the Washington Hospital Center, Washington, D.C.

"The investigational GALILEO system with automated stepping allows Guidant's intravascular radiotherapy system to more easily treat patients with longer coronary blockages," said Dr. Waksman. "This new automated system also is intended to enable physicians to more easily perform radiotherapy procedures by automatically determining the number of steps required to treat a particular lesion and automatically performing those steps."

Trial Background and Results

The GALILEO INHIBIT (INtimal Hyperplasia Inhibition with Beta In-stent Trial) trial was a prospective, single-arm historical control trial and enrolled 135 patients in 10 centers worldwide. The trial was designed to study the safety and efficacy of Guidant's next generation GALILEO Intravascular Radiotherapy System, an investigational device, with automated stepping for the treatment of in-stent restenosis. It uses a new 20 mm source that is automatically stepped to produce equivalent source lengths of 40-60 mm.

Results from this trial will be used to file a Pre-Market Approval Application Supplement with the FDA for the next-generation GALILEO Intravascular Radiotherapy System.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to 7 million cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 10,000 employees, develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life's most threatening medical conditions.